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Global trends in clinical trials involving pluripotent stem cells: a systematic multi-database analysis
Julia Deinsberger1,2, David Reisinger1, Benedikt Weber1,2
1Disease Modeling and Organoid Technology (DMOT) Research Group, Department of Dermatology, Medical University of Vienna, Vienna, Austria.
NPJ Regenerative Medicine
|September 28, 2020
Summary
Clinical trials using pluripotent stem cells (PSCs) are increasing, but most are observational. Interventional studies, particularly those using embryonic stem cells (ESCs), are fewer but show promise in specific fields like ophthalmology.
Area of Science:
- Regenerative Medicine
- Stem Cell Biology
- Clinical Research
Background:
- Pluripotent stem cells (PSCs) offer therapeutic potential for tissue regeneration.
- Despite advancements in induced pluripotent stem cell (iPSC) technology, no PSC-based therapy is in routine clinical use.
- Understanding clinical trial trends is crucial for advancing PSC applications.
Purpose of the Study:
- To analyze research trends in clinical trials involving pluripotent stem cells (PSCs).
- To differentiate between observational and interventional PSC studies.
- To identify geographical and therapeutic focuses of PSC clinical trials.
Main Methods:
- Data sourced from ClinicalTrials.gov and WHO ICTRP.
- A multistep search algorithm and stringent inclusion/exclusion criteria were applied.
- 131 clinical trials involving PSCs were identified and analyzed.
Main Results:
- Most PSC trials (77.1%) were observational, with limited cell transplantation.
- Interventional trials (22.9%) predominantly used embryonic stem cells (ESCs) (73.3%).
- Induced pluripotent stem cell (iPSC) trials (74.8%) outnumbered ESC trials (25.2%) overall.
- Interventional trials were significantly shorter than observational trials (p=0.002).
- Observational trials concentrated in the USA and France; interventional trials in Asia (China, Japan, South Korea).
- Ophthalmology was a key focus for interventional studies.
Conclusions:
- A limited number of PSC trials focus on actual patient transplantation.
- Current PSC clinical research is concentrated in specific diagnostic areas.
- The future clinical success of iPSC technology remains to be determined.
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